🇺🇸 Fetroja in United States

FDA authorised Fetroja on 14 November 2019

Marketing authorisation

FDA — authorised 14 November 2019

  • Application: NDA209445
  • Marketing authorisation holder: SHIONOGI
  • Local brand name: FETROJA
  • Indication: POWDER — INTRAVENOUS
  • Status: approved

The FDA approved Fetroja, a cephalosporin antibiotic, for various indications on June 6, 2025. Fetroja is manufactured by Shionogi, the marketing authorization holder. The approval was granted through the standard expedited pathway.

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Fetroja in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in United States

Frequently asked questions

Is Fetroja approved in United States?

Yes. FDA authorised it on 14 November 2019.

Who is the marketing authorisation holder for Fetroja in United States?

SHIONOGI holds the US marketing authorisation.